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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00503360
Registration number
NCT00503360
Ethics application status
Date submitted
17/07/2007
Date registered
18/07/2007
Date last updated
24/04/2008
Titles & IDs
Public title
Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension
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Scientific title
A Multicenter, Randomized, Placebo-Controlled, Double-Masked, 4-Arm Parallel Group Study to Assess the Tolerability, Safety and Efficacy of Two Doses of SAD448 in Subjects With Ocular Hypertension
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Secondary ID [1]
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CSAD448B2101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ocular Hypertension
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SAD448
Treatment: Drugs: SAD448
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs from baseline up to 24 hours post-dosing.
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Change in ocular hypertension from baseline up to 24 hours post-dosing. Systemic exposure to SAD448 following the administration of two doses.
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
Key inclusion criteria:
- Males and females, 18 - 65 years of age, with ocular hypertension
- Females must be post-menopausal or surgically sterile
Key exclusion criteria:
- Diagnosis of glaucoma in either eye
- A history of or current eye conditions or medical problems that would prohibit the use
of an investigational drug
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Novartis Investigative site, Sydney, Australia - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the tolerability and safety of SAD448 and explore the compound's
effect on intraocular pressure in subjects with ocular hypertension.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00503360
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis
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Address
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Novartis
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00503360
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